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A multicenter, randomized, double-blind, placebo-controlled clinical trial to compare the efficacy and safety of nalbuphine hydrochloride combined with propofol with that of sufentanil combined with propofol in painless colonoscopy

A multicenter, randomized, double-blind, placebo-controlled clinical trial to compare the efficacy and safety of nalbuphine hydrochloride combined with propofol with that of sufentanil combined with propofol in painless colonoscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094007
Enrollment
Unknown
Registered
2024-12-16
Start date
2024-12-17
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal disease

Interventions

Group A: Nalbuphine hydrochloride combined with propofol:Nalbuphine hydrochloride combined with propofol
Group B: Sufentanil in combination with propofol:Sufentanil in combination with propofol

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18 to 75, gender limitation; 2.Meet the indications for painless colonoscopy, such as requiring gastroenteroscopy for the diagnosis or treatment of gastrointestinal diseases; 3.No history of related drug allergy, especially to nalbuphine hydrochloride and propofol; 4.No serious cardiopulmonary diseases, such as heart failure, serious arrhythmia, serious respiratory diseases, etc; 5.Liver and kidney function was basically normal, with no history of severe liver and kidney insufficiency; 6.Able to understand and cooperate with the study requirements, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of severe cardiopulmonary diseases, such as heart failure, severe arrhythmia, severe respiratory diseases, etc.; 2. Liver and kidney insufficiency, with a history of severe liver and kidney dysfunction; 3. History of mental illness, such as epilepsy, schizophrenia, etc.; 4. Pregnant or lactating women; 5. Recent use of drugs that may affect the results of the study, such as analgesics, sedatives, antidepressants, etc.; 6. Unable to understand and cooperate with the research requirements, such as language communication disorders, cognitive impairments, etc.; 7. Those who participated in any clinical trial as a subject within 3 months prior to enrollment; 8. Other circumstances judged by the investigator to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Analgesia effect (use discomfort score);

Secondary

MeasureTime frame
depth of sedation (MOAA / S score);patient satisfaction (assessed using the satisfaction questionnaire);

Countries

China

Contacts

Public ContactYan Zhenyi

Affiliated Hospital of Guangdong Medical University

453356755@qq.com+86 759 2387429

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026